Brand Name | MALYUGIN RING SYSTEM |
Type of Device | IRIS CLIP RETRACTOR |
Manufacturer (Section D) |
MICROSURGICAL TECHNOLOGY, INC. |
redmond WA |
|
Manufacturer Contact |
|
8415 154th ave., n.e. |
redmond, WA 98052
|
4255560544
|
|
MDR Report Key | 4632489 |
MDR Text Key | 5754155 |
Report Number | 3019924-2015-00014 |
Device Sequence Number | 1 |
Product Code |
HOC
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Not Applicable
|
Remedial Action |
Replace |
Type of Report
| Initial |
Report Date |
03/19/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Expiration Date | 11/01/2017 |
Device Model Number | MAL-0001-1 |
Device Catalogue Number | MAL-0001-1 |
Device Lot Number | 065149 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 02/27/2015 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
02/17/2015
|
Initial Date FDA Received | 03/19/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/01/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|